Associate Manager - QMS Central Quality

Zydus Healthcare Limited; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Zydus Lifesciences Corporate Office, Ahmedabad, Gujarat, India is seeking a senior QA professional with 11–16 years of experience to oversee site QMS documents for adequacy and completeness as per SOP. You will review deviations, investigations, change controls, qualifications, process validation, APQR, and QMS trend reports, and prepare actionable observations.

Discuss gaps with site SME/QA Head/LCQ/HTO for resolution, ensure closure with supporting documents, perform trend analyses, identify

Qualifications

• 1116 years of experience in quality assurance or quality management roles.

Responsibilities

• Overview of site QMS documents as per SOP “Overview of Quality Management system documents by CQ” to verify adequacy and completeness.
• Review QMSELEMENTS inclusive: Deviations, Process Investigations (OOS-Phase II), Change controls, Qualification (Equipment and Utilities), Process validation, APQR, QMS Trend reports.
• Prepare a report with appropriate categorizations and scaling of actionable observations.
• Discuss identified gaps with site SME / QA Head / Lead Central Quality (LCQ) / Head Technical Operation (HTO) for resolution.
• Review site compliance reports and follow up for adequate closure with supporting documents.
• Conduct trend analysis of observations to identify systemic areas for improvement.
• Identify areas for improvement based on trends and organize training as needed.
• Prepare monthly reports and participate in departmental meetings.
• Present summaries of observations to LCQ / HTO and management on a periodic basis.
• Elevate issues to management for compliance and support; assist in regulatory and external inspections for site readiness.
• Present summaries to management periodically; participate in central quality audits as needed; provide concurrence to audit observations and compliance; assist in preparing/revising Corporate SOPs, guidelines & policies; manage soft copy data; perform other activities assigned by HOD/Management.

Job description

Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

11 - 16 Years

Job Description

Sr.No.

Overviewof site QMS documents as per SOP “Overview of Quality Management systemdocuments by CQ” to verify its adequacy and completeness.

QMSELEMNETS TO BE REVIEWED INCLUSIVE OF :

• Deviations
• Process Investigations (OOS-Phase II)
• Change controls
• Qualification (Equipment and Utilities )
• Process validation
• APQR
• QMS Trend report’s

Toprepare a report with appropriate categorizations and scaling of allactionable observations.

Todiscuss the gaps identified during review with site SME / QA Head / LeadCentral Quality (LCQ) / Head Technical Operation (HTO) for resolution.

Review ofsite compliance report as applicable and follow ups for adequate closurethrough appropriate supporting documents from site.

Trendanalysis of observation for identification of systemic areas for improvement.

Identifyspecific area of improvement based on emerging trend and provide / organizetraining to the site as and when required.

Toprepare monthly reports and participate in departmental meeting.

Topresent summary of observations to Lead Central Quality (LCQ) / HeadTechnical Operation (HTO) and management on periodic basis.

Toidentify and elevate specific issue to management for compliance andsupport.

To assistin regulatory and external inspection for site readiness

Topresent summary of observations to management on periodic basis.

Toparticipate in periodic central quality audits to laid down quality systemstaking holistic view on the product quality & patient safety; as &when required.

Toprovide concurrence to the audit observations & compliance as & whenneeded.

To assistin preparation / revision of Corporate SOPs, Guidelines & Policies whenrequired.

Soft copydata management of reviewed documents.

Anyadditional activity assigned by HOD / Management.

Job Snapshot

Updated Date

07-10-2026

Job ID

JOB9331

Department

CENTRAL QUALITY

Location

Location Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.